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Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma (LIFT)

Primary Purpose

Follicular Lymphoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HCD122
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma focused on measuring HCD122, Lucatumumab, CD40, Follicular Lymphoma, Non-Hodgkin's Lymphoma, Antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification
  • Documented CD40+ follicular lymphoma
  • Measurable lesion
  • Refractory to rituximab
  • Prior treatment with at least 1 chemotherapeutic regimen
  • 18 years or older
  • WHO Performance Status grade 0, 1, or 2
  • Life expectancy > 3 months
  • Obtained written informed consent

Exclusion Criteria:

  • Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
  • History of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Prior allogeneic stem cell transplantation
  • Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
  • Impaired cardiac function or clinically significant cardiac disease
  • History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
  • History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
  • Known diagnosis of human immunodeficiency virus (HIV) infection
  • Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
  • Ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Dana Farber Cancer Institute SC-5
  • Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
  • Duke University Medical Center Duke Hem & Onc
  • Sarah Cannon Research Institute SC - 2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCD122

Arm Description

Outcomes

Primary Outcome Measures

Incidence rate of dose-limiting toxicities and adverse events

Secondary Outcome Measures

Response rate

Full Information

First Posted
January 10, 2011
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01275209
Brief Title
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
Acronym
LIFT
Official Title
A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
HCD122, Lucatumumab, CD40, Follicular Lymphoma, Non-Hodgkin's Lymphoma, Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCD122
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HCD122
Other Intervention Name(s)
Lucatumumab
Primary Outcome Measure Information:
Title
Incidence rate of dose-limiting toxicities and adverse events
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification Documented CD40+ follicular lymphoma Measurable lesion Refractory to rituximab Prior treatment with at least 1 chemotherapeutic regimen 18 years or older WHO Performance Status grade 0, 1, or 2 Life expectancy > 3 months Obtained written informed consent Exclusion Criteria: Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL) History of another primary malignancy that is currently clinically significant or currently requires active intervention Prior allogeneic stem cell transplantation Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration Impaired cardiac function or clinically significant cardiac disease History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment. Known diagnosis of human immunodeficiency virus (HIV) infection Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C Ongoing corticosteroid use (>10 mg/day prednisone or equivalent) Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Dana Farber Cancer Institute SC-5
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Duke University Medical Center Duke Hem & Onc
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Sarah Cannon Research Institute SC - 2
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8184
Description
Results for CHCD122A2104 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

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